The Recall Desk
SevereFDA (Drugs)·D-1096-2020·Announced 2020-04-15

Innovative Compounding Pharmacy Recalls MIC-8 Injectable Due to Sterility Concerns

Innovative Compounding Pharmacy is recalling MIC-8 injectable vials because the firm cannot assure the product's sterility. Patients in California, Maine, and Texas should stop using the product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable) corresponds to a score of 4 (Severe), as it is not explicitly Class I but involves a serious potential hazard.

Plain-English summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml), a 10 mL injectable prescription product. The recall was initiated because the firm lacks assurance of the product's sterility.

The affected product includes Lot # 03022020@64, which expires after 05-18-2020, and Lot # 01032020@51, which expires after 04-02-2020. The distribution list indicates that the product was shipped to patients in California, Maine, and Texas.

Patients who have received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Manufacturer
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 03022020@64
  • Expires after 05-18-2020
  • Lot # 01032020@51
  • Expires after 04-02-2020

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

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Same hazard · sterility

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